NCT04492696

Brief Summary

Importance: Concussion underreporting leads to delays in diagnosis and treatment, resulting in prolonged recovery. Athletes' report of concussion symptoms is therefore an important component of risk reduction. Numerous educational interventions to improve concussion knowledge and reporting exist. Objective: Evaluate the comparative efficacy of three concussion education programs in improving concussion-reporting intention. Design: Randomized clinical trial conducted from August 2018 to October 2018, with assessment before, immediately after, and one-month after educational intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
Last Updated

July 30, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

July 23, 2020

Last Update Submit

July 27, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Improvement in concussion reporting intention among athletes

    All primary and secondary outcomes, besides those related to concussion knowledge, were assessed based on athlete responses, on a 10-point Likert type scale ranging from 1=strongly disagree to 10=strongly agree, to specific questions related to that domain. A composite measure for each outcome was created by summing athletes' responses and dividing by the number of questions asked, resulting in outcomes scaled from 1 to 10. A composite measure created based on the inverse of athlete responses to five questions about their concussion-reporting intention (i.e., whether they would continue playing with a concussion during "the beginning of the season," "a practice," "the middle of the season," "during a championship game," and "at the end of the season").

    1 month

Secondary Outcomes (4)

  • Improvement in concussion knowledge among athletes

    1 month

  • Improvement in concussion attitudes among athletes

    1 month

  • Improvement in concussion perceived normative beliefs among athletes

    1 month

  • Improvement in concussion perceived behavioral control among athletes

    1 month

Study Arms (3)

Crashcourse

ACTIVE COMPARATOR

CC uses an approach to providing concussion education informed by user-centered formative design research studies. The program features an interactive "choose your own adventure" approach to navigate the learner through the content, and is guided by near-peer Division I collegiate football athletes

Other: Education

CDC Video

ACTIVE COMPARATOR

CDC-Vi is an online learning module developed by the CDC and the National Federation of State High School Associations Learning Center. Learners progress through the curriculum sequentially completing each unit before proceeding to the next. The primary narrator of CDC-Vi is Dr. Mick Koester, Chair of the NFHS Sports Medicine Advisory Committee

Other: Education

CDC Written

ACTIVE COMPARATOR

CDC-Wr consists of educational PDFs available for download from the CDC website, as part of the CDC's "Heads Up" brain injury awareness initiative. The PDFs used for the CDC-Wr condition were specific to high school athlete concussion education

Other: Education

Interventions

Education

CDC VideoCDC WrittenCrashcourse

Eligibility Criteria

Age14 Years - 19 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsAmerican football players
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Athletes from three high school football teams in California.
  • In attendance for practice on both study dates
  • Provided signed assent and parental consent.

You may not qualify if:

  • Did not complete more than 50% of the questionnaire.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 23, 2020

First Posted

July 30, 2020

Study Start

August 1, 2018

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

July 30, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Via contact with study PI, and pending approval of IRB

Shared Documents
STUDY PROTOCOL

Locations